Sleep Apnea is a sleep disturbance (disorder) characterized by abnormal pauses in breathing or instances of abnormally low breathing, during sleep. An “apnea”, or basically a pause in breathing can typically last from a few seconds to minutes, and may occur many times over a period of an hour. In one form of sleep apnea, commonly known as the Obstructive Sleep Apnea (OSA), a patient's normal breathing is interrupted by a physical block. As a result, not enough air reaches a patient's lungs, resulting in decreased airflow to the lungs, and consequently, snoring. Common symptoms of OSA include loud snoring, restless sleep, and consequently, fatigue and sleepiness during the daytime. Further, a patient suffering from obstructive sleep apnea can also suffer a stroke. Even further, patients suffering from sleep apnea can have memory loss due to reduced flow of oxygen to the brain caused by the decreased airflow to the lungs.
Conventionally, continuous positive airway pressure (CPAP) is one treatment for obstructive sleep apnea. CPAP treatments usually involve a patient wearing a mask or a similar device that fits over a patient's nose, or covering both the nose and the mouth of a patient. Usually, a tube connects the mask to a motor that blows air into the mask through the tube. The air pressure can be adjusted based on the needs and comfort level of the patient being treated. Generally it is the doctor's responsibility to decide what pressure setting is appropriate for the patient. There are many available masks with many variations. But, many patients have difficulty in tolerating forced air. Thus, claustrophobia and feelings of suffocation and/or panic attacks are also frequent complaints for patients who are treated using CPAP. Masks can also create sores, acne ulcers or annoying skin eruptions. Dry eyes from leaky masks can also be one annoying condition.
Other methods of treatment of sleep apnea include nasal valves, surgeries (e.g., to remove and tighten tissue around the airway to the lungs), and dental devices. Such surgeries can involve tongue repositioning, procedures concerning the patient's sinuses and valves, and various palatal techniques. However, surgeries can cause morbidity—pain and swallowing difficulties (i.e., patients have to be on soft diet for long periods of time). Patients who have undergone surgeries can also have difficulties in taste and speech. Also, conventional electrosurgical procedures cause deep thermal penetration because of the high temperatures (usually, 400 degrees Celsius to 600 degrees Celsius) used in the procedure. In many cases, even after performing surgeries, symptoms of sleep apnea can relapse after some time. Moreover, surgical procedures, if at all, can be performed on adults who are able to undergo surgical procedures.
In one traditional method of treating sleep apnea, RF ablation (RFA) devices are used to create lesions (typically four or more) at the base of the patient's tongue. Usually, such a method involves the doctor taking extra precaution so that the patient's lingual artery and hypoglossal and lingual nerves are avoided. The concept behind RFA involves dissociating soft tissue using bipolar radiofrequency energy. The devices comprise electrolytes in a conductive medium. A precisely focused plasma field (RF field) is created by exciting electrolytes in the conductive medium. As a result, energized particles or ions in the plasma field get sufficient energy to break organic molecular bonds within soft tissue at relatively low temperatures (usually, 40° C. to 70° C.).
Traditional methods involving RF ablation devices for treating sleep apnea can be painful and can also result in undesirable health complications of a patient. Examples of such complications include hematoma, dysphagia, dysarthria, deformity, aspiration, and other undesirable complications. Consequently, patients treated using traditional RF ablation methods have to be hospitalized and intubated, thereby increasing medical costs and exposing patients to health risks.
Therefore, there is a long-felt but unresolved need for an improved medical device and associated tools and methods or procedures that treat sleep apnea without causing swelling or hematoma of a patient's tongue. Further, the improved procedure should cause significantly less pain to a patient, should preferably not involve intubation or hospitalization of any kind. Even further, the procedure should result in reduced morbidity arising from changes in swallowing. Also, the procedure should minimize the risk of relapse of the symptoms of sleep apnea.